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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 019358

AZO GANTRISIN (PHENAZOPYRIDINE HYDROCHLORIDE; SULFISOXAZOLE)
50MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: PHENAZOPYRIDINE HYDROCHLORIDE; SULFISOXAZOLE
Proprietary Name: AZO GANTRISIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N019358
Product Number: 001
Approval Date: Aug 31, 1990
Applicant Holder Full Name: HOFFMANN LA ROCHE INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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